← Product Code [DJC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJC) · K031497

# AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST (K031497)

_Amedica Biotech, Inc. · DJC · Oct 17, 2003 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJC/K031497

## Device Facts

- **Applicant:** Amedica Biotech, Inc.
- **Product Code:** [DJC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJC.md)
- **Decision Date:** Oct 17, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3610
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration: MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml; BAR secobarbital 300 ng/ml; BZO oxazepam 300 ng/ml; MTD methadone 300 ng/ml; TCA nortriptyline 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

## Device Story

Lateral flow immunochromatographic assay for qualitative drug detection in human urine. Available as dipstick or cassette format. Operator dips strip or adds urine drops to sample well; sample migrates through test strip. Visual readout of test lines indicates presence or absence of specific drugs at defined cutoffs. Intended for professional use in clinical laboratories; not for point-of-care. Results are preliminary; requires GC/MS confirmation. Assists healthcare providers in identifying potential drug use; clinical judgment required for interpretation.

## Clinical Evidence

Performance evaluated via correlation study using blind-labeled specimens compared against GC/MS. Study demonstrated >94% agreement with GC/MS results. Clinical site study performed at a certified laboratory confirmed professional utility for visual, qualitative drug detection.

## Technological Characteristics

Membrane-based lateral flow competitive immunoassay; utilizes colloidal gold for visual detection. Employs specific antibody-antigen reactions. Standalone test kit; no electronic components or software.

## Regulatory Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

## Special Controls

*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

## Predicate Devices

- Instant-View MDMA Test ([K022501](/device/K022501.md))
- Instant-View Barbiturate Test ([K010125](/device/K010125.md))
- Instant-View Benzodiazepine Test ([K003879](/device/K003879.md))
- Instant-View Methadone Test ([K010014](/device/K010014.md))
- Instant-View TCA Test ([K022693](/device/K022693.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## DECISION SUMMARY
## DEVICE ONLY TEMPLATE

A. 510(k) Number:
K031497

B. Analyte:
3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone, nortriptyline

C. Type of Test:
qualitative

D. Applicant:
Amedica Biotech, Inc.

E. Proprietary and Established Names:
Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA

F. Regulatory Information:
1. Regulation section:
21 CFR862.3610; 21 CFR862.3150; 21 CFR862.3170; 21 CFR862.3620; 21 CFR862.3910
2. Classification:
Class II
3. Product Code:
DJC; DIS; JXM; DJR; MLK
4. Panel:
Clinical Toxicology Panel (91)

G. Intended Use:
1. Intended use(s):
See Indications for use.
2. Indication(s) for use:
The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an immunochromatographic assay for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cutoff concentration

|  3,4 methylenedioxymethamphetamine | 500 ng/ml  |
| --- | --- |
|  secobarbital | 300 ng/ml  |
|  oxazepam | 300 ng/ml  |
|  methadone | 300 ng/ml  |
|  nortriptyline | 1000 ng/ml  |

This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter use.

3. Special condition for use statement(s):
Not intended for point of care sites. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be

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used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when preliminary results indicated positive.

4. Special instrument Requirements:
Not applicable. The device is a visually read single-use device.

H. Device Description:
For the Test Strip: the product is a single-use dipstick device. Operators dip the test strip into the urine and the reaction is initiated by movement of the sample through the test strip.

For the Test Card: the product is a single-use device in a cassette format. Operators add several drops of the sample to the sample well. The test reaction is initiated by movement of the sample through the test strip.

I. Substantial Equivalence Information:

1. Predicate device name(s):
Instant-View MDMA Test, Alfa Scientific Design, Inc.
Instant-View Barbiturate Test, Alfa Scientific Design, Inc.
Instant-View Benzodiazepine Test, Alfa Scientific Design, Inc.
Instant-View Methadone Test, Alfa Scientific Design, Inc.
Instant-View TCA Test, Alfa Scientific Design, Inc.

2. Predicate K number(s):
K022501; K010125; K003879; K010014; K022693

3. Comparison with predicate:
Both devices are for the qualitative determination of the same analytes in the same matrix, and utilize the same cutoff concentration. Both are visually-read single use devices.

J. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standard/guidance in this submission.

K. Test Principle:
The test employs lateral flow immunochromatographic technology.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
The product has been evaluated (1) random error of visual interpretation by three different observers interpreting duplicate tests on a single sample source 2 times a day for 20 days, and (2) random error of multiple observers interpreting a single test. Five urine

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specimens near cutoff concentration were prepared by spiking GC/MS confirmed standard solution into filtered drug free urine. Test results are as follows:

|  MDMA | No. of | 1 |   | 2 |   | 3  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  con. ng /ml | Samples | - | + | - | + | - | +  |
|  250 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  375 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  5uc | 120 | b4 | 66 | 54 | 66 | 54 | 66  |
|  625 | 120 | 25 | 95 | 25 | 95 | 24 | 96  |
|  750 | 120 | 0 | 120 | 0 | 120 | 0 | 120  |
|  BAR | No. of | 1 |   | 2 |   | 3  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  conc. ng /ml | Samples | - | + | - | + | - | +  |
|  150 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  225 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  300 | 120 | 63 | 57 | 63 | 57 | 63 | 57  |
|  375 | 120 | 30 | 90 | 30 | 90 | 31 | 89  |
|  450 | 120 | 0 | 120 | 0 | 120 | 0 | 120  |
|  BZO | No. of | 1 |   | 2 |   | 3  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  conc. ng /ml | Samples | - | + | - | + | - | +  |
|  150 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  225 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  300 | 120 | 56 | 64 | 54 | 66 | 54 | 66  |
|  375 | 120 | 35 | 85 | 33 | 87 | 35 | 85  |
|  450 | 120 | 0 | 120 | 0 | 120 | 0 | 120  |
|  MTD | No of | 1 |   | 2 |   | 3  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  conc. ng /ml | Samples | - | + | - | + | - | +  |
|  150 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  225 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  300 | 120 | 54 | 66 | 52 | 68 | 52 | 68  |
|  375 | 120 | 37 | 83 | 36 | 84 | 36 | 84  |
|  450 | 120 | 0 | 120 | 0 | 120 | 0 | 120  |
|  TCA | No of | 1 |   | 2 |   | 3  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Conc ng /ml | Samples | - | + | - | + | - | +  |
|  500 | 120 | 120 | 0 | 120 | 0 | 120 | 0  |
|  750 | 120 | 120 | 0 | 130 | 0 | 120 | 0  |
|  1000 | 120 | 59 | 61 | 58 | 62 | 57 | 63  |
|  1250 | 120 | 38 | 82 | 37 | 83 | 37 | 83  |
|  1500 | 120 | 0 | 120 | 0 | 120 | 0 | 120  |

b. Linearity/assay reportable range: Not applicable. The assay is intended for qualitative use.

c. Traceability (controls, calibrators, or method): The device has an internal control. Users are instructed to follow federal, state, and local guidelines concerning the running of external quality controls.

d. Detection limit: The analytical sensitivity of Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test were evaluated using the following 7 different

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urine specimens with drug concentration ranging from negative to 3x cutoff. The specimens were prepared by spiking GC/MS confirmed drug standards into filtered drug free urine. The results of the sensitivity study are summarized as follows:

|  MDMA Conc. (ng/ml) | No. of samples | - | +/- | +  |
| --- | --- | --- | --- | --- |
|   | 25 | 25 | 0 | 0  |
|  250 | 25 | 25 | 0 | 0  |
|  375 | 25 | 12 | 13 | 0  |
|  500 | 25 | 0 | 11 | 14  |
|  625 | 25 | 0 | 5 | 20  |
|  750 | 25 | 0 | 0 | 25  |
|  1500 | 25 | 0 | 0 | 25  |
|  BAR Conc. (ng/ml) | No. of samples | - | +/- | +  |
| --- | --- | --- | --- | --- |
|  0 | 25 | 25 | 0 | 0  |
|  150 | 25 | 25 | 0 | 0  |
|  225 | 25 | 11 | 14 | 0  |
|  300 | 25 | 0 | 13 | 12  |
|  375 | 25 | 0 | 7 | 18  |
|  450 | 25 | 0 | 0 | 25  |
|  900 | 25 | 0 | 0 | 25  |
|  BZO Conc. (ng/ml) | No of samples | - | +/- | +  |
| --- | --- | --- | --- | --- |
|  0 | 25 | 25 | 0 | 0  |
|  150 | 25 | 25 | 0 | 0  |
|  225 | 25 | 10 | 15 | 0  |
|  300 | 25 | 0 | 12 | 13  |
|  375 | 25 | 0 | 0 | 17  |
|  450 | 25 | 0 | 0 | 25  |
|  900 | 25 | 0 | 0 | 25  |
|  MTD Conc (mg/ml) | No of samples | - | +/- | +  |
| --- | --- | --- | --- | --- |
|  0 | 25 | 25 | 0 | 0  |
|  150 | 25 | 25 | 0 | 0  |
|  225 | 25 | 11 | 14 | 0  |
|  300 | 25 | 0 | 11 | 14  |
|  375 | 25 | 0 | 8 | 17  |
|  450 | 25 | 0 | 0 | 25  |
|  900 | 25 | 0 | 0 | 25  |
|  TCA Conc. (ng/ml) | No of samples | - | +/- | +  |
| --- | --- | --- | --- | --- |
|  0 | 25 | 25 | 0 | 0  |
|  125 | 25 | 25 | 0 | 0  |
|  18.75 | 25 | 10 | 15 | 0  |
|  25 | 25 | 0 | 13 | 12  |
|  31.25 | 25 | 0 | 9 | 16  |
|  37.5 | 25 | 0 | 0 | 25  |
|  75 | 25 | 0 | 0 | 25  |

# e. Analytical specificity:

The specificity of Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA has been tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in filtered drug-free normal human urine.

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The following structurally related compounds produce positive results when tested at levels greater than the concentrations listed below.

|  Compound | Concentration (ng/ml)  |
| --- | --- |
|  MDMA |   |
|  3,4 methylenedioxymethamphetamine (MDMA) | 500  |
|  d-Methamphetamine | 250  |
|  d-amphetamine | 10,000  |
|  1-Methamphetamine | 500  |
|  Methylenedioxyethylamphetamine (MDEA) | 500  |
|  p-Methoxyamphetamine (PMA) | >100,000  |
|  34 methylenedioxyamphetamine (MDA) | >100,000  |
|  BAR |   |
|  Secobarbital | 300  |
|  Alphenal | 400  |
|  Amobarbital | 2,000  |
|  Aprobarbital | 300  |
|  Barbital | 300  |
|  Butabarbital | 300  |
|  Butalbital | 3,000  |
|  Pentobarbital | 400  |
|  Phenobarbital | 300  |
|  BZO |   |
|  Oxazepam | 300  |
|  Alprazolam | 200  |
|  Bromazepoxide | 1,500  |
|  Chlordiazepoxide | 500  |
|  Clobazam | 400  |
|  Clonazepam | 50,000  |
|  Diazepam | 300  |
|  Estazolam | 500  |
|  Flunitrazepam | 1,500  |
|  Flurazepam | 1,000  |
|  Lorazepam | 3,000  |
|  Lometazepam | 10,000  |
|  Medazepam | 50,000  |
|  Nitrazepam | 20,000  |
|  Nordiazepam | 400  |
|  Prazepam | 5,000  |
|  Temazepam | 3,000  |
|  Triazolam | 50,000  |

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# MTD

Methadone 300
(±)-2-Ethyl-1,5-dimethyl-3,3-diphenylpyrrolinium 50,000
2-Ethyl-5-methyl-3,3-diphenylpyrroline (EMDP) 50,000

# TCA

Nortriptyline 1,000
Amitriptyline 1,000
Desipramine 800
Imipramine 1,000
Nordoxepline 1,500
Cyclobenzaprine 3,000
Clomipramine 10,000
Doxepine 1,500
Protriptyline 3,000
Perphenazine 50,000
Promazine 30,000
Trimipramine 5,000

The following compounds were found not to cross-react when tested at concentrations of 100 ug/ml.

Acetaminophen, Acetone, Albumin, Ampicillin, Aspartame, Atropine, Benzocaine, Bilirubin, Caffeine, Chloroquine, Chlorpheniramine, Creatine, Dexbrompheniramine, Dextromethorphan, 4-Dimethylamincantipyrine, Dopamine, Doxylamine, (+/-)-Ephedrine, Erythromycin, Ethanol, Furosemide, Gualacol Glyceryl Ether, Glucose, Hemoglobin, Isoproterenol, N-Methyl-Ephedrine, (+)-Naproxen, Oxalic Acid, Penicillin-G, Pheniramine, Phenothiazine, L-Phenvleohrine, β-Phenylethylamine, Procaine, Quin CBHBHNNHG idine, Ranitidine, Sodium Chloride, Sulindac, Thioridazine, Tyramine, Vitamin C

There is a possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., biological, technical or procedural error. Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test performance was evaluated using cutoff specimen and found no interferences when pH is between 4.5 to 8.5 and specific gravity is between 1.005 to 1.03.

f. Assay cut-off:

The identified cutoff except for MTD and TCA are recommended for use by Substance Abuse and Mental Health Services Administration (SAMHAS).

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Page 7 of 8

2. Comparison studies:

a. Method comparison with predicate device:
The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test accuracy has been evaluated using urine samples from clinical laboratories where they were analyzed by reference method, GC/MS. The test agreement with GC/MS results are as follows:

MDMA

|  New test | GC/MS Negative < -25% | GC/MS Negative -25% to cutoff | GC/MS Positive Cutoff to +25% | GC/MS Positive >+25% | % agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- |
|  + | 0 | 2 | 7 | 41 | 94.1  |
|  - | 55 | 9 | 3 | 0 | 97.0  |

BAR

|  New test | GC/MS Negative < -25% | GC/MS Negative -25% to cutoff | GC/MS Positive Cutoff to +25% | GC/MS Positive >+25% | % agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- |
|  + | 0 | 2 | 12 | 42 | 96.4  |
|  - | 45 | 13 | 2 | 0 | 96.7  |

BZO

|  New test | GC/MS Negative < -25% | GC/MS Negative -25% to cutoff | GC/MS Positive Cutoff to +25% | GC/MS Positive >+25% | % agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- |
|  + | 0 | 2 | 9 | 31 | 97..6  |
|  - | 67 | 12 | 1 | 0 | 97..5  |

MTD

|  New test | GC/MS Negative < -25% | GC/MS Negative -25% to cutoff | GC/MS Positive Cutoff to +25% | GC/MS Positive >+25% | % agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- |
|  + | 0 | 3 | 8 | 44 | 96.3  |
|  - | 51 | 13 | 2 | 0 | 95.2  |

TCA

|  New test | GC/MS Negative < -25% | GC/MS Negative -25% to cutoff | GC/MS Positive Cutoff to +25% | GC/MS Positive >+25% | % agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- |
|  + | 0 | 2 | 8 | 47 | 94.8  |
|  - | 50 | 8 | 3 | 0 | 96.6  |

b. Matrix comparison:
Not Applicable. The assay is intended for only one sample matrix.

3. Clinical studies:

a. Clinical sensitivity: NA

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b. Clinical specificity: NA
c. Other clinical supportive data (when a and b are not applicable): None

4. Clinical cut-off: NA
5. Expected values/Reference range: NA

**M. Conclusion:**

Based on the information provided, I recommend that the Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is substantially equivalent to the legally marketed predicate device.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJC/K031497](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJC/K031497)

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